Obesity is a condition defined by having an excessive amount of body fat. As of 2006, there are an estimated 70 million obese people in the United States. By some estimates, there are 1 billion obese individuals worldwide. In addition, hospital costs associated with childhood obesity have risen from about $35 million in 1979 to $127 million in 1999. Obesity not only affects the quality of life and productivity of those effected, it has also been proven to lead to long-term health related complications, such as diabetes, heart disease, hypertension, cancer, and a myriad of gastrointestinal maladies. Some researchers estimate that if the obesity epidemic is not brought under control, the number of adults with type II diabetes could skyrocket in the next decade.
Surgical treatments, for example, stomach stapling and bypass operations, are methods for inducing substantial weight loss in obese people. The mechanism behind the success of these surgical treatments is unclear because obesity is such a complex condition. Some researchers propose that surgery does no more than provide biofeedback for appetite retraining. Other researchers maintain that surgery alters the physiology of the patient such that satiety is induced earlier or fewer nutrients are absorbed. Regardless, the consensus among most obesity researchers is that at the current time, long-term weight loss is achievable by surgical means and that the success of surgery is due to a myriad of biological changes.
However, despite the efficacy of surgical procedures, they remain highly invasive and carry significant morbidity, including ubiquitous surgical complications such as infection, high incidence of pulmonary morbidity such as pneumonia and pulmonary embolism, and risk of leakage at the surgical site, which can result in a spectrum of consequences ranging from an extended hospital stay to death. Furthermore, surgery is a poor option for adolescents in whom the long-term consequence of malabsorption of nutrients is not known. In addition, many patients resist such irreversible, life altering procedures.
Dietary supplements have also been used to impart of feeling of satiety, to slow gastric transit of nutrients within a patient, and to reduce the impulse to eat. For example, fiber supplements may be ingested orally and swell within a patient's stomach to promote a temporary feeling of fullness. However, fiber supplements only remain within the stomach for a short period of time, and therefore do not provided a sustained feeling of satiety that fully promotes weight loss. Also, the gastrointestinal side effects of ingesting fiber supplements can be severe. For example, the more the fiber consumed by a patient, the greater the chance that the fiber will cause bloating, abdominal pain, and diarrhea. As such, only a small volume of fiber may be consumed at any one time, limiting its efficacy. Moreover, in order to obtain any benefit from fiber supplements, they need to be taken at least once a day, typically prior to a meal, for many days, thus creating a risk that patients may forget to ingest them or ingest too many.
Alternatively, recent attempts have been made to use an intragastric balloon to displace volume within the stomach such that a smaller volume of food leads to an earlier feeling of satiety. Currently, intragastric balloons on the market can lead to complications such as obstruction and mucosal erosion. Additionally, the incidence of nausea, vomiting, and epigastric pain may be present owing to the balloon having a tendency to obstruct the passage of food out of the stomach. This obstructive tendency is due in part because current intragastric balloon devices are filled with saline, which acts as ballast, and causes the balloon to sink to the bottom of the stomach and obstruct the pylorus.
Accordingly, what is needed is a temporary gastric device that is minimally invasive, avoids obstructing the passage of food out of the stomach, and achieves effective results.